Anal Cancer and/or Precancer Screening: Performance Analysis of the BD Onclarity™ HPV Assay on Anal Specimens

March 22, 2024 updated by: European Institute of Oncology

Anal Cancer and/or Precancer Screening: Performance Analysis of the BD Onclarity HPV Assay on Anal Specimens

Human papillomavirus (HPV) infection has been implicated as a necessary cause for the development of the majority of anogenital neoplasms which represent approximately 95% of anal tumors. Persistent high risk HR-HPV infection promotes progression from intraepithelial lesions high-grade squamous anal tumors (AIN) (H-SIL) to invasive anal tumors.

The diagnosis of AIN is made by cytology or biopsy during routine examinations. To date, no HPV test has been clinically validated for anal specimens and none are available in the molecular diagnostics market for this purpose.

The performance analysis of an HPV Test with simultaneous genotyping on anal samples could implement anal cancer screening without an invasive procedure and with one simple approach.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Anal cancer is a rare disease in the general population, but its incidence is higher in certain at-risk groups, such as immunosuppressed individuals, including those with HIV infections and post-organ transplantation patients, men who have sex with men, and women with HPV-related lower genital tract dysplasia or cancer.

A squamous intraepithelial anal lesion is the dysplastic growth of squamous epithelial cells in the transition zone of the anal canal. This lesion is pre-malignant and can progress to anal squamous cell carcinoma if left untreated.

Human papillomavirus (HPV) infection has been implicated as the necessary cause for the development of the majority of anogenital malignancies accounting for approximately 95% of anal cancers. Persistent infection with HR-HPV promotes progression from high-grade squamous intraepithelial lesions (H-SIL) to invasive anal cancers. In the anal canal, low-grade intraepithelial lesion LSIL correlates with anal intraepithelial neoplasia (AIN)-1 or anal condyloma, while high grade squamous intraepithelial lesion HSIL correlates with AIN-2 and AIN-3.

Prevalence of H-SIL is around 40 to 50%. Progression from H-SIL to anal cancer is about 1/250 per year in HIV-positive MSM and 1/5000 per year in HIV-negative MSM, respectively.

The diagnosis of AIN is made from cytology or biopsy during routine examinations.

Up to date, different guidelines for anal cancer screening have been proposed but are not uniform. These include 1) digital ano-rectal examination, useful in unrecognized but symptomatic subjects, and 2) anal cytology, useful in asymptomatic subjects, only if high-resolution anoscopy is available.

These observations support the need to implement screening to prevent anal precancers and cancers.

At this moment, no HPV assay has been validated for anal specimens, and none is available in the molecular diagnostics market.

Validation of HPV typing methods on anal specimens could implement anal cancer screening without an invasive procedure and with an easy approach for the patient.

The BD Onclarity™ HPV Assay (BD Diagnostics, Sparks, USA) is a real-time polymerase chain reaction PCR assay that detects type-specific genomic DNA. The target of the assay is the E6 and E7 HPV genes. It simultaneously detects all 14 high-risk HPV types and can provide an "extended" genotype information on six individual genotypes (HPV 16, 18, 31, 45, 51 and 52), and in three distinct groups (33 and 58; 56, 59 and 66; and 35,39 and 68). Briefly, the DNA was extracted using BD FOX™ magnetic particles and the eluate-containing DNA was used to set up three PCR genotyping reactions: G1 detects HPV 16, HPV 18 and HPV 45 plus the internal beta globin control; G2 detects HPV 31, HPV 33_58 and HPV 56_59_66 plus the internal beta globin.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy
        • Recruiting
        • European Institute of Oncology
        • Contact:
          • Fabio Bottari
        • Sub-Investigator:
          • Cristina Trovato, MD
        • Sub-Investigator:
          • Anna Daniela Iacobone, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Sampling Method

Probability Sample

Study Population

Patients who come at the European Institute of Oncology at high risk of anal cancer undergoing cancer screening anal, colorectal, or on an outpatient basis for HPV-related pathologies.

Description

Inclusion Criteria:

  • Subjects older than 18 years old
  • Subjects with histological-confirmed high-grade anal intraepithelial neoplasia (AIN2+) or anal invasive cancer
  • Subjects with histological-confirmed low-grade anal intraepithelial neoplasia (AIN1)

  • Subjects at high-risk for anal cancers, including:

    1. Immunocompromised subjects (patients with HIV infection, or taking immunosuppressive drugs, or post-organ transplantation)
    2. Men who have sex with men (MSM)
    3. Women aged at least 40 years with a history of cervical intraepithelial neoplasia CIN2+ and/or vulvar cancer
    4. Subjects affected by anal and/or peri-anal localizations of Crohn's disease
  • Subjects undergoing colorectal cancer screening
  • Signed written consent.

Exclusion Criteria:

  • Refuse to sign written consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Case patients
Histological-confirmed high-grade anal intraepithelial neoplasia (AIN2+ and 3+) and invasive cancer; patients with macroscopic anal lesion.
Control patients
Histological-confirmed low-grade anal intraepithelial neoplasia (AIN1), and subjects at high-risk for anal cancers, including: Immunocompromised subjects (patients with HIV infection, or taking immunosuppressive drugs, or post-organ transplantation); Men who have sex with men (MSM); Women aged at least 40 years with a history of CIN2+ and/or vulvar cancer; Subjects affected by anal and/or peri-anal localizations of Crohn's disease.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of BD Onclarity HPV assay for HPV detection and genotyping in case/control patients.
Time Frame: 4 years
To evaluate to use of BD Onclarity HPV assay for HPV detection and genotyping from the anus, without endoscope. This study aims to enroll 100 cases and 100 controls to evaluate the performance of the Onclarity test in detecting the presence of HPV in anal swab samples that will be placed in a Thin Prep vial (Hologic), in order to perform cytology and the BD Onclarity assay, a qualitative target-amplification test based on RT-PCR and fluorescent probe technology to detect E6 and E7 DNA regions of the HPV genome; Onclarity provides genotyping information on six individual genotypes (HPV 16, 18, 31, 45, 51 and 52) and reports the remaining HPV genotypes in three distinct groups (33/58, 35/39/68, and 56/59/66). The assay has an internal human beta-globin (HBB) gene control for sample adequacy and assay performance. Sensitivity, specificity of the Onclarity test will be evaluated.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 17, 2022

Primary Completion (Estimated)

June 17, 2026

Study Completion (Estimated)

June 17, 2029

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

March 18, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IEO 1663

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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